The Colder Fluids - Intravenous Infusion of 10 Degrees Celsius Fluids and Its Effects on Circulation and Hemostasis

Esbjerg Hospital - University Hospital of Southern Denmark

Status and phase: Completed; Phase 1

Conditions: Hemodynamic Instability

Treatments: Drug: Ringer's Lactate

Study type: Interventional

Funder types: Other

Identifiers

NCT06622499

2023-506018-35-00

Details and patient eligibility

About

The aim of this study is to investigate the effect of respectively 10 and 22 degrees Celsius Ringer's lactate solution on the physiological response in healthy adults. In a single center crossover study the investigators will include and randomize 25 healthy volunteers to receive 1 liter of Ringer's lactate either cold (10°C, 50°F), or at room temperature (22°C, 71,6°F) with 100 ml/min. Fluids will be administered through a peripheral vein. After a minimum "washout period" of 24 hours, subjects are switched to receive infusion at the other aforementioned temperatures.

The main outcomes of this study are:

Primary:

• The increase in Mean Arterial Pressure (MAP) 30 minutes after started infusion

Secondary:

• Time until return of MAP to baseline value after infusion.
• Changes in Visual Analog Scale (VAS) of discomfort during infusion
• Changes in temperature, blood pressure, heart rate, peripheral oxygen saturation cardiac index, cardiac output, total peripheral resistance index and stroke volume
• Changes in the intravascular volume status and the fluid responsiveness
• Changes in biochemical parameters at baseline, 30 and 60 minutes.
• Changes in Rotational thromboelastometry (ROTEM) analysis at baseline, 30 and 60 minutes

Enrollment: 25 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age between 18-64

Exclusion criteria

• Pre-existing medical problems that are contraindicated for cold crystalloid infusions.
• Pregnancy (validated through a certified urine pregnancy test)
• Body mass index >35 kg/m2
• Medication use, including over-the-counter anti-pyretics within 48 hours, with exception of allergy medication and contraceptives.
• Any family history or predisposition of coagulopathies.
• Any intake of inhibitors of 11β-Hydroxysteroid dehydrogenase the past 48 hours (products containing liquorice)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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25 participants in 2 patient groups

Cold - Room temperature

Active Comparator group

Description:

Trial day 1: Participants receive Ringer's lactate cold (10°C, 50°F), Trial day 2: Participants receive Ringer's lactate at room temperature (22°C, 71.6°F)

Treatment:

Drug: Ringer's Lactate

Room temperature - Cold

Active Comparator group

Description:

Trial day 1: Participants receive Ringer's lactate at room temperature (22°C, 71.6°F), Trial day 2: Participants receive Ringer's lactate cold (10°C, 50°F)

Treatment:

Drug: Ringer's Lactate